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    Summary
    EudraCT Number:2014-002155-25
    Sponsor's Protocol Code Number:TAK-448-2001
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-08-18
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2014-002155-25
    A.3Full title of the trial
    An Open-Label, Phase 2a Study to Evaluate the Pharmacodynamics of Different Dosing Regimens of TAK-448, a Kisspeptin Agonist, in Male Overweight/Obese Subjects With Hypogonadotropic Hypogonadism
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Correcting low testosterone levels in men with diabetes: A new treatment approach
    A.4.1Sponsor's protocol code numberTAK-448-2001
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorTakeda Development Centre Europe Ltd
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportTakeda Development Centre Europe Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTakeda Development Centre Europe Ltd
    B.5.2Functional name of contact pointRudi Taljaard
    B.5.3 Address:
    B.5.3.1Street Address61 Aldwych
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeWC2B 4AE
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+4402031168156
    B.5.6E-mailrudi.taljaard@takeda.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTAK-448 0.2 mg/2 mL
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot Yet Known
    D.3.9.2Current sponsor codeTAK-448
    D.3.9.3Other descriptive namePeptide analog of kisspeptin
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.3 to 30
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hypogonadotropic Hypogonadism
    E.1.1.1Medical condition in easily understood language
    Low testosterone levels
    E.1.1.2Therapeutic area Body processes [G] - Reproductive physiologi cal processes [G08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10021012
    E.1.2Term Hypogonadotrophic hypogonadism
    E.1.2System Organ Class 100000004860
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effects on Serum Testosterone(ST) after 4 weeks of SC dose administration, with different doses and dosing frequencies of TAK-448 to overweight/obese subjects with Hypogonadotropic Hypogonadism.
    E.2.2Secondary objectives of the trial
    To evaluate pharmacokinetics (PK) of TAK-448 free base form (TAK-448F) after a single SC dose and after 4 weeks of repeated SC dose administration with different doses and dosing frequencies of TAK-448.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.In the opinion of the investigator, the subject is capable of understanding and complying with protocol requirements.
    2.The subject or, when applicable, the subject’s legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
    3.The subject has two morning total ST concentrations of ≤12.0 nmol/L ( ≤3.46 ng/mL) taken during the Screening period.
    4.The subject is male and aged 18 to 60 years, inclusive.
    5.The subject has a body mass index (BMI) between 25.0 and 50.0 kg/m2, inclusive.
    6. If diagnosed with T2DM, the subject has a HbA1c concentration <12% at Screening and is on a stable dose of diabetes therapies (including insulin and/or glucagon-like peptide-1 therapies).
    7.The subject has a LH concentration <8 IU/L at Screening.
    8.A male subject who is nonsterilized* and sexually active with a female partner of childbearing potential* agrees to use adequate contraception* from signing of informed consent throughout the duration of the study and for 12 weeks after last dose.
    *Definitions and acceptable methods of contraception are defined in Section 9.1.10 Contraception and Pregnancy Avoidance Procedure and reporting responsibilities are defined in Section 9.1.11 Pregnancy of the protocol.

    E.4Principal exclusion criteria
    1.The subject has received any investigational compound within 30 days prior to Screening.
    2.The subject has received TAK-448 in a previous clinical study, or previous cohort.
    3.The subject is an immediate family member, study site employee, or is in a dependant relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
    4.The subject has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality (other than T2DM, its complications and associated conditions), which may impact the ability of the subject to participate or potentially confound the study results.
    5.The subject has a recent history or clinical manifestations of significant CVD – such as a history of myocardial infarction or stroke in the 6 months preceding the Screening visit or has untreated peripheral arterial disease.
    6.The subject has a history of hypersensitivity or allergies to any component of the formulation of TAK-448.
    7.The subject has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 5 years prior to Screening.
    8.The subject is required to take excluded medications, supplements, or food products listed in Section 7.3.
    9.The subject intends to donate sperm during the course of this study or for 12 weeks after the last dose of study drug.
    10.The subject has clinical evidence of anatomic or pathological hypothalamic/pituitary disease.
    11.There is any finding in the subject’s medical history, physical examination, or safety laboratory tests giving reasonable suspicion of a disease that would contraindicate taking TAK-448, or a similar drug in the same class that might interfere with the conduct of the study.
    12.The subject has a history of cancer (including prostate cancer), with the exception of basal cell carcinoma which has been in remission for at least 5 years prior to Screening.
    13.The subject has a history of or present symptomatic prostate disease (including benign prostatic hyperplasia) or PSA is >4 ng/mL at Screening.
    14.The subject has a known history of human immunodeficiency virus infection at Screening.
    15.The subject is deemed by the study team to have poor peripheral venous access.
    16.The subject has donated or lost 450 mL or more of his blood volume (including plasmapheresis), or had a transfusion of any blood product within 45 days prior to Screening, or is planning to donate blood for 12 weeks after the last dose of study medication.
    17.The subject has a Screening or Day -1 abnormal (clinically significant) ECG. Entry of any subject with an abnormal (not clinically significant) ECG must be approved, and documented by signature of the principal investigator or medically qualified subinvestigator.
    18.The subject has abnormal Screening or Day -1 laboratory values that suggest a clinically significant underlying disease or subject with the following lab abnormalities: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >2× the upper limits of normal (ULN).
    19.The subject, in the opinion of the investigator, is unlikely to comply with the protocol or is unsuitable for any other reason.
    20.The subject has had more than two severe hypoglycemic events (requiring third party assistance) within 6 months prior to the Screening Visit.
    21.The subject has a diagnosis of type 1 diabetes mellitus.
    22.The subject has a history of diabetic ketoacidosis.
    E.5 End points
    E.5.1Primary end point(s)
    •Percent change from Baseline in area under the effect curve from time 0 to 72 hours (AUEC72) of total ST after 4 weeks of SC dosing with TAK-448 (Day 25 for twice-weekly dosing, Day 22 for once-weekly dosing).
    •Percent change from Baseline in AUEC72 of free ST after 4 weeks of SC dosing with TAK 448 (Day 25 for twice-weekly dosing, Day 22 for once-weekly dosing).
    •Trough serum concentration (Ctrough defined as lowest Baseline compared to predose of the last dose) of total ST after 4 weeks of SC dosing.
    •Ctrough (lowest Baseline compared to predose of the last dose) of free ST after 4 weeks of SC dosing.
    E.5.1.1Timepoint(s) of evaluation of this end point
    4 weeks (Day 22 for once - week dosing and or Day 25 for twice-week dosing)
    E.5.2Secondary end point(s)
    •Cmax of TAK-448F after first dose (Day 1) and after final dose.
    •Area under the plasma concentration time curve of TAK-448F from time 0 to infinity (AUC∞) after first dose (Day 1) and after final dose.
    •Area under the plasma concentration-time curve of TAK-448F from time 0 to time of the last quantifiable concentration (AUCt) after first dose (Day 1) and after 4 weeks of dosing.
    •Terminal elimination half life (t1/2z) of TAK-448F after single (Day 1) and multiple dose (after 4 weeks of dosing).
    E.5.2.1Timepoint(s) of evaluation of this end point
    After first dose (Day 1) and after 4 weeks of dosing (final dose)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    sequential/parallel
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial6
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA1
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 48
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state48
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Thames Valley and South Midlands
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-10-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-11-17
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2015-12-04
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